Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06202352 |
| Other study ID # |
B.30.2.ATA.0.01.00/585 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2024 |
| Est. completion date |
September 15, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose of the research; To determine the effect of basic yoga techniques and meditation
intervention on midwifery students' anxiety and perceived stress levels.
Yoga is alternative mind-body exercises that aim to establish a connection between the brain
and body. Derived from the Sankiritic term "yuj", yoga means to integrate. Yoga techniques
focus on self-awareness and require careful coordination of body movements/postures (asanas),
deep breathing (pranayama) and meditation. Yoga can be used as a complementary and
alternative method for various diseases or improving well-being. Yoga is becoming
increasingly important in improving mental health. In this planned study, we aim to manage
the anxiety and perceived stress that students studying in the field of health mostly suffer
from with yoga techniques.
After the sociodemographic data of the volunteer participants who agree to take part in the
research are identified and recorded in the first stage, the screening phase, according to
the power analysis, the minimum number of participants determined will be assigned to the
experimental and control groups by randomization. In the second stage of the research, the
experimental group; Yoga techniques and meditation practices (once a week for 8 weeks) will
be performed at times when anxiety and stress are most intense (before exams, laboratory and
hospital applications). Students in the control group will continue their routine coping
habits with anxiety and stress. Students will complete pre- and post-intervention surveys to
assess changes in anxiety and perceived stress. The anxiety and stress levels of students in
both groups will be determined by applying the "Beck Anxiety Inventory" and the "Perceived
Stress Scale" before and after the intervention. The data obtained after the interventions
will be compared with appropriate statistical analysis and converted into a report.
The proposed research aims to provide scientific research skills and experience to the 2nd
year students of Atatürk University, Faculty of Health Sciences, Department of Midwifery, who
are involved in the project. In addition, it is expected that the proposed project will show
how it affects the anxiety and perceived stress levels of midwifery students in the
international media and literature and emphasize its positive effects on the management of
the well-being of these individuals.
Description:
Introduction Derived from the Sanskrit word "yuj", yoga means integrated awareness of mind
and body. Yoga techniques are popular practices that include the coordination of different
posture techniques, deep breathing practices and meditation (Sarbacker and Kimple, 2015).
Since yoga is a mental exercise that slows down brain waves, it can help eliminate negative
emotions and ensure awareness and cognitive balance (Desai et al., 2015). It has been
understood that controlling perceived stress not only reduces mood disorders, but also
provides better sensorimotor performance and hand grip endurance (Bajunaid et al., 2015).
Midwifery is a discipline in which theory and practice are carried out in an integrated
manner, and it requires the completion of difficult, complex graduation criteria regarding
the prenatal, intraparum and postpartum processes (Aydın Kartal and Yazıcı, 2017; Nehir and
Güngör Tavşanlı, 2021). In general, in studies conducted on midwifery students, it is
observed that stress and anxiety are inevitably high (Aydın Kartal and Yazıcı, 2017; Nehir
and Güngör Tavşanlı, 2021). Since today's midwifery students will be the expert midwives of
the future, the physical and mental health of midwifery students can increase the welfare of
society. In this context, teaching midwifery students to connect with their body and mind may
increase psychological well-being.
According to the results of a limited number of studies, yoga exercises provided positive
effects on medical/health education students suffering from intense stress and anxiety
(Erogul et al., 2014; Fares and Fares, 2016). The limited number of studies conducted in the
field of health education on the effects of yoga and meditation focused on students of
medicine, pharmacy and nursing departments (Lemay et al., 2019; Ciezar-Andersen et al.,
2021). On the other hand, despite the popularity of yoga in studies mostly in western
societies (Shohani et al., 2018), to our knowledge, how it prevents mood disorders in the
field of midwifery has not been studied. Studies on the effects of yoga are limited in
Turkey.
Method The total screening of the project will be carried out in 2 stages. In the first
stage, students' anxiety and stress levels will be screened. After the screening study,
students' demographic characteristics, general anxiety and perceived stress levels will be
measured. According to the data obtained from the scanning study, the numbered forms will be
put in order and the data obtained will be recorded in the IBM SPSS (Statistical Package for
the Social Sciences) Statistic 21 package program. According to the data obtained as a result
of the screening study, participants (72 students) who will be sampled according to their
anxiety and perceived stress levels will be assigned to the yoga techniques and control
group. A randomization program (www.randomize.org) will be used to assign groups.
Students assigned to groups through randomization will be contacted via their contact numbers
and will be informed about the research and which group they will be in. Appointments will be
made with students assigned to study groups, and yoga/meditation techniques will begin in a
suitable room at the faculty. Meetings will be arranged with the yoga and control groups
determined during the selection phase, after the lesson hours of each class. Two separate
WhatsApp groups will be created: control and yoga groups. The responsible researcher has an
international yoga training certificate.
Yoga and meditation practices (8 weeks, once a week, 60 minutes):
The yoga and meditation intervention will use a 60-minute vinyasa yoga class once a week,
followed by a guided yoga instruction booklet that takes an average of 30 minutes to read.
The intervention will be carried out in the last eight weeks of the spring semester, when
hospital practices are most intense and before the final exams. Posttest forms will be filled
out the week of final exams. The time devoted to meditation will be increased every week for
the last two weeks, starting with 5 minutes and gradually increasing to 20 minutes in the
eighth week.
- Application Place(s) of the Research: It will be carried out in a suitable room at
Atatürk University, Faculty of Health Sciences, Department of Midwifery.
- Details of Study Design and Method:
The planned study is a pre-posttest-posttest, randomized controlled experimental study.
• Sample Size Population and Sample of the Research: The population of the study will consist
of 724 registered students studying at Atatürk University, Faculty of Health Sciences,
Department of Midwifery (1st, 2nd, 3rd, 4th Grade) in the 2023-2024 academic year. The
maximum number of students (sample) to be included in the study was calculated using G*Power
3.1.9.7 software. Taking Shohani et al.'s (2018) study titled "The Effect of Yoga on Stress,
Anxiety, and Depression in Women" as a reference, it was determined that the effect size of
the difference between pre- and post-training individuals in the experimental group who
received yoga training was 0.351. Accordingly, the sample size required for 80% (1-β=0.80)
power at d = 0, 351 and α = 0.05 was calculated as 33 people from each group. Considering the
possibility of midwifery students leaving the groups during the research, it was decided that
the number of samples in the groups would be 36, based on a 10% loss. Students who do not
meet the inclusion criteria for the study will not be included in the randomization.
Since it is aimed to reach all midwifery students in the survey study, no sample selection
will be made. In order to reach eligible students later after the screening, students'
contact information will be written in the surveys and the scales will be numbered. At this
stage; 72 students who meet the inclusion criteria for this study and volunteer will be
divided into control and yoga groups. The dependent variables of the study are yoga and
meditation. Independent variables are anxiety level and perceived stress level. Additionally,
students will have to sign an Informed Consent Form.
• Collecting Study Data and Recording Data Data Collection Tools Sociodemographic data of
midwifery students will be recorded with the "Student Identification and Monitoring Form"
prepared by the research team. In addition, the "Beck Anxiety Scale" and "Perceived Stress
Scale" will be used for the screening study, before and after the intervention.
Student Diagnosis and Monitoring Form (ANNEX-1) Student Identification and Follow-up Form to
be used in collecting research data: A form will be used to inquire about the situations
related to name, surname, class, age, height, weight, age, marital status, place of
residence, mother and father's working status and attitude towards exercise. This information
will be filled in by self-report method.
Beck Anxiety Scale (BAI) (ANNEX-2) The scale evaluates the severity of generalized anxiety
symptoms. This instrument focuses on somatic symptoms of anxiety and contains 21 items.
Responses are based on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely),
with a maximum total score of 63. Scores between 0 and 21 indicate low anxiety, scores
between 22 and 35 indicate moderate anxiety, and scores of 36 and above indicate high
anxiety. The scale was adapted to the Turkish sample by Durak and Palabıyıkoğlu (Durak and
Palabıyıkoğlu, 1994).
Perceived Stress Scale (PSS) (Annex-3) It was adapted into Turkish by Eskin et al. (2013).
Measuring stress is important for scientific research and application activities to be
carried out in our country. ASÖ reliability coefficient was calculated as 0.87 (Eskin et al.,
2013). The scale in question consists of 14 items (Erci, 2006). The scale has two subscales:
Perception of Insufficient Self-Efficacy and Perception of Stress/Discomfort; Items 1, 2, 3,
7, 11, 12 and 14 constitute the Perception of Stress/Discomfort dimension, and items 4, 5, 6,
8, 9, 10 and 13 constitute the Perception of Insufficient Self-Efficacy dimension. In the
scale, items 4, 5, 6, 7, 9, 10 and 13 are scored reversely. The total score determined as a
result of the scale application indicates the stress level. It shows low stress level between
11-26 points, medium stress level between 27-41 points, and high stress level between 42-56
points.
• Application of Research The total screening of the project will be carried out in 2 stages.
In the first stage, students' anxiety and stress levels will be screened. After the screening
study, students' demographic characteristics, general anxiety and perceived stress levels
will be measured. According to the data obtained from the scanning study, the numbered forms
will be put in order and the data obtained will be recorded in the IBM SPSS (Statistical
Package for the Social Sciences) Statistic 21 package program. According to the data obtained
as a result of the screening study, participants (72 students) who will be sampled according
to their anxiety and perceived stress levels will be assigned to the yoga techniques and
control group. A randomization program (www.randomize.org) will be used to assign groups.
Students assigned to groups through randomization will be contacted via their contact numbers
and will be informed about the research and which group they will be in. Appointments will be
made with students assigned to study groups, and yoga/meditation techniques will begin in a
suitable room at the faculty. Meetings will be arranged with the yoga and control groups
determined during the selection phase, after the lesson hours of each class. Two separate
WhatsApp groups will be created: control and yoga groups. The responsible researcher has an
international yoga training certificate.
- Description of Transactions on Working Days & Visits (if any) Students currently
studying at Atatürk University, Faculty of Health Sciences, Department of Midwifery,
will be informed about the research and invited to participate in the research. Research
data will be collected from students who agree to participate in the research using a
survey form and face-to-face interview technique.
- Randomization Method & Importance (if any) Randomization will be provided in an online
program. A randomization program (www.randomize.org) will be used to assign groups.
Students assigned to groups through randomization will be contacted via their contact
numbers and will be informed about the research and which group they will be in.
- Ensuring Patient Compliance (if any) Before starting the research, approval will be
obtained from the non-invasive ethics committee of Atatürk University Faculty of
Medicine and official permission will be obtained from the Midwifery Department of
Atatürk University Faculty of Health Sciences. Midwifery students within the scope of
the research will be informed about the research and their informed consent will be
obtained before starting to collect research data. In addition, ethical principles
including the principle of "confidentiality and protection of confidentiality" will be
fulfilled by stating that the information obtained from the students will be kept
confidential, and the principle of "respect for autonomy" will be fulfilled by
recruiting those who want to participate in the research voluntarily.
- Ensuring volunteer participation and obtaining consent, defining the procedures to be
taken in the volunteers' special situations.
Informed voluntary consent, given with the completely free will of the students who will
participate in the research, will be obtained from all volunteers before the research is
initiated. Information regarding the clinical trial will be recorded in a manner that allows
for accurate reporting, interpretation and verification of this information.
- Materials to be Used & Storage Conditions & Responsibilities (if any) Records regarding
the identity of volunteers will be protected in a way that respects the rules of private
life and confidentiality in accordance with the relevant legislation. Survey forms will
be kept by the principal investigator for at least five years.
- Statistical & Analytical Methods should be clearly stated in this section. After yoga
practices are completed, post-test forms (Perceived Stress Scale and Beck Anxiety Scale)
will be administered. The data obtained as a result of the study will be recorded in the
IBM SPSS (Statistical Package for the Social Sciences) Statistic 21 package program and
statistical analysis will be performed.
First of all, Kolmogorov-Smirnov Goodness of Fit Test and "Shapiro-Wilk" will be applied for
normality analysis in determining the test to be performed. In descriptive statistics,
arithmetic mean, standard deviation, median, minimum and maximum values will be applied, and
frequency and percentage will be applied to categorical variables. Cronbach's Alpha
Coefficient will be calculated to test the internal consistency of the scales. "Pearson
Chi-square Test and Fisher's Exact Test" will be applied to compare the descriptive
characteristics between the study and control groups. Within-group paired sample t -test to
compare pre- and post-intervention results, based on established normality.
(Paired-Samples T test) will be applied. In determining the difference between the two group
averages, t-test will be applied in independent groups. The statistical significance level
will be accepted as 0.05.
